FindMyRecallSubscribe
Class I: serious health riskTerminated

Performance Plus Marketing CASANOVA Capsules Recall

CASANOVA Capsules, 450 mg, MALE SEXUAL ENHANCER, supplied i n1 count blister packs

Performance Plus Marketing, Inc. · Commerce, CA

Risk level
Class I
Reported by FDA
May 22, 2013
Recall ID
D-338-2013
Check your lot numberHow we source this data

Summary

Performance Plus Marketing recalled CASANOVA Capsules starting Dec 17, 2012. The FDA classified it as Class I (serious health risk) and published enforcement report D-338-2013 on May 22, 2013. Reason: Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients, making them unapproved drugs. Status: Terminated.

Why it was recalled

Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients, making them unapproved drugs

Product description

CASANOVA Capsules, 450 mg, MALE SEXUAL ENHANCER, supplied i n1 count blister packs, UPC 736211906892; Distributed by: Casanova Distributors, Tucker, GA

Lot numbers, UPCs & expiration codes

Lot# 030112, Exp: 03/15

Where it was sold

Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-338-2013
Classification
Class I
Status
Terminated
Recall initiated
Dec 17, 2012
FDA report date
May 22, 2013
Quantity
96,000 capsules.
Recall type
Voluntary: Firm initiated
Recalling firm
Performance Plus Marketing, Inc.

Original FDA data

Every field from FDA enforcement report D-338-2013, exactly as published.

Show all FDA fields
City
Commerce
State
CA
Status
Terminated
Country
United States
Event ID
63916
Address
5560 E 61st St
Code information
Lot# 030112, Exp: 03/15
Postal code
90040-3406
Report date
May 22, 2013
Product type
Drugs
Recall number
D-338-2013
Classification
Class I
Recalling firm
Performance Plus Marketing, Inc.
Product quantity
96,000 capsules.
Termination date
Nov 14, 2013
Reason for recall
Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients, making them unapproved drugs
Voluntary / mandated
Voluntary: Firm initiated
Product description
CASANOVA Capsules, 450 mg, MALE SEXUAL ENHANCER, supplied i n1 count blister packs, UPC 736211906892; Distributed by: Casanova Distributors, Tucker, GA
Distribution pattern
Nationwide
Recall initiation date
Dec 17, 2012
Initial firm notification
Telephone
Center classification date
May 16, 2013

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-338-2013, published May 22, 2013. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

How we source and update recall data · Report incorrect information

Other recent drug recalls